On April 3, 2015, parents from Billings Yellowstone County, Montana, filed a lawsuit against GlaxoSmithKline under case number: 1:15-cv-00026-SPW-CSO in the United States District Court, District of Montana Billings Division. The lawsuit alleges that Zofran, an anti-emetic that blocks seratonin, caused the congenital birth defect that their daughter was diagnosed with upon delivery. This is one of several lawsuits filed against GSK in 2015 alleging that the drug caused child birth defects. To read about the other lawsuits, click here.

To download the complaint filed in Montana, click on the button below.

Montana Complaint Alleges Cleft Palate Caused By Zofran

M.M., the child of the parents in the complaint, was born in 1998. The plaintiff mother was prescribed and took Zofran during the first trimester of her pregnancy with M.M to treat severe morning sickness. Upon being delivered, M.M. was diagnosed with cleft lip and palate. The complaint continued to outline the severe hardship and recovery that M.M. and her family had to endure. M.M. underwent ten surgeries, in the first 16 years of her life, to correct her cleft lip and palate and the complaint outlined that this birth defect impaired the development of M.M. at home and at school. There is no family history of cleft palate.

Other Child Birth Defects Associated With Zofran

As of April 2015, several lawsuits have been filed against GSK. Below is a listing of the birth defects that were named in each of the lawsuits with a link to a summary of each lawsuit’s allegations:

What Is Cleft Palate?

A cleft palate is a form of orofacial cleft that occurs during the formation of the oral tissues, which typically occurs during weeks 8 and 12 of pregnancy. A cleft palate occurs when these tissues fail to fuse properly leaving a hole or cleft in the roof of the mouth. Sometimes the cleft will extend to cause a cleft lip and leave a hole in the lip which can continue up through the nasal cavity. For more information about cleft palates, see our page on orofacial clefts. We also recommend visiting the Cleft Lip and Palate Foundation of Smiles, which is a non profit organization where great information and support is shared to parents of children with cleft issues.

What Associates Cleft Palate To Zofran?

The complaint outlined several epidemiological studies performed by the medical community which measured populations of births where Zofran / Ondansetron was taken for morning sickness during the first trimester. In particular, the complaint highlighted a study conducted by the US Centers for Disease Control, researchers at Harvard University, and Boston University’s Slone Epidemiology Center. The conclusion of this study suggested that women who took Zofran during the first trimester were 2.37 times more likely to deliver a child with a cleft palate. For more information on the studies, view our infographic.

What To Do If Your Child Has Cleft Palate And You Took Zofran?

If you are a concerned parent, and you are interested in more information about Zofran and the studies that suggest an increased likelihood of congenital child birth defects, then please contact one of our Zofran lawyers. We are fielding questions from concerned parents around the US and Canada regarding their specific situation. Each person has unique circumstances, and our lawyers are experienced and compassionate. We will assess your facts, and advise you on your legal options. If you or someone you know delivered a child who was diagnosed with a cleft palate, or other birth defect, and they took Zofran for morning sickness, then contact the ZofranLegal.com team for free. We are available 24/7.

About Post Author

Michael Monheit, Esq. is an experienced mass torts lawyer. Michael is the parent of a child with developmental delay and special needs. He also sits on the board for The Cleft Lip And Palate Foundation of Smiles. Michael has been appointed lead plaintiffs' counsel in several mass tort lawsuits.

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